What are the responsibilities and job description for the Senior Manager, CMC Quality Control position at Digital Prospectors?
Position:Senior Manager, CMC Quality Control
Location:Brisbane, CA (Hybrid - 2 days onsite, approx. 35 hours/week)
Length:6 months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking an experienced and motivated Senior Manager, CMC Quality Control (QC) to support clinical and commercial programs. This individual will play a critical role in managing quality control operations for biologics, ensuring compliance with regulatory requirements, and supporting the development of life-changing medicines. The ideal candidate will have a deep understanding of biologics manufacturing, analytical methodologies, and regulatory expectations (FDA, EMA, ICH). This is an exciting opportunity to join a high-performing team focused on delivering innovative therapies for patients with rare and ultra-rare diseases.
Essential Duties and Responsibilities (but not limited to):
Come see why DPC has achieved:
As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!
www.LoveYourJob.com
Location:Brisbane, CA (Hybrid - 2 days onsite, approx. 35 hours/week)
Length:6 months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking an experienced and motivated Senior Manager, CMC Quality Control (QC) to support clinical and commercial programs. This individual will play a critical role in managing quality control operations for biologics, ensuring compliance with regulatory requirements, and supporting the development of life-changing medicines. The ideal candidate will have a deep understanding of biologics manufacturing, analytical methodologies, and regulatory expectations (FDA, EMA, ICH). This is an exciting opportunity to join a high-performing team focused on delivering innovative therapies for patients with rare and ultra-rare diseases.
Essential Duties and Responsibilities (but not limited to):
- Lead quality control support for clinical and commercial biologics programs, ensuring compliance with cGMP, ICH, and global regulatory standards.
- Oversee analytical method development, validation, and transfer activities for biologics and related products.
- Review, manage, and organize QC data, including release and stability reports, and generate interim trending assessments.
- Partner with Contract Manufacturing Organizations (CMOs) and contract labs to manage QC testing for release, stability, and method validation/transfer.
- Support QC operations for development, manufacturing, and regulatory activities, ensuring timely completion of deliverables.
- Participate in stability programs and data trending per ICH, FDA, EMA, USP, and Ph. Eur. guidelines.
- Maintain and implement quality systems to ensure integrity and reliability of QC data.
- Initiate and manage quality documentation, including deviations, CAPAs, and change controls in electronic quality systems (e.g., Veeva).
- Assist in OOE/OOS/OOT investigations and ensure resolution aligns with regulatory expectations.
- Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related field.
- 3 years in analytical/QC within a GMP environment (pharma or biotech).
- Strong knowledge of biologics drug substance processes (upstream and downstream).
- Experience with stability studies per ICH guidelines and familiarity with QC methodologies.
- Proficiency with MS Office and statistical analysis software (Excel, JMP preferred).
- Excellent organizational, project management, and communication skills.
- Pay range $140,000 - $160,000 depending on experience.
Come see why DPC has achieved:
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor.
- Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!
www.LoveYourJob.com
Salary : $140,000 - $160,000